DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED3. For generic product please provide supportingdocuments e.g. Martindale or equivalentdocument to support the change.4. For natural products, please provide:a) Justification for the proposed change.b) Supporting documents from the clinicalpapers, Chinese Pharmacopoeia and/orherbal monograph/ compendium on thetherapeutic uses and safety aspect of therelevant active ingredient/s.3. Change in content of labelinclusive of change ingraphics/ artwork.D1D2D3D1D2D3CONDITIONSFor Natural Products Please refer to (List ofProhibited Visuals/ Graphics On Label of NaturalProducts in Appendix 5)SUPPORTING DOCUMENTRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 466
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED4. Change in manufacturingprocess of the finishedproductE11P3.2P3.2.1P3.3P3.4P5.1P5.4P8B2.1B2.2B3B4B5F10(CoA offinishedproduct)CONDITIONS1. The same currently approved manufacturing site.2. The change does not cause a negative impact onthe quality, safety and efficacy of the drug product.3. Finished product specification is not adverselyaffected.SUPPORTING DOCUMENTS1. Description of the proposed change inmanufacturing process.2. Comparative batch analysis data between thecurrently approved and proposed manufacturingprocesses OR Certificate of Analysis (CoA), whereapplicable.3. Stability data of drug product (please refer toASEAN Guideline on Stability Study of DrugProduct) where applicable.4. Comparative dissolution profile data between theproducts manufactured in the currently approvedand proposed manufacturing process for oral soliddosage forms as per compendium and validationbatches, where applicable.5. Justification for not submitting a newbioequivalence study according to ASEANGuidelines for the Conduct of Bioavailability andBioequivalence Studies, where applicable.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 467
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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